Devices and methods for minimally invasive suturing

ABSTRACT

Devices and methods for minimally invasive suturing are disclosed. One suturing device for minimally invasive suturing includes a proximal section a distal end, and an intermediate region therebetween. The device includes a suture head assembly having a suturing needle with a pointed end and a second end. The suturing needle is capable of rotating about an axis approximately perpendicular to a longitudinal axis of the device, wherein the pointed end of the suturing needle is positioned within the suture head assembly prior to deployment of guides that are adapted and configured to guide the needle around a circular path when advanced by a drive mechanism having a needle driver for engaging and rotating the suturing needle.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of and claims the benefit ofpriority of U.S. patent application Ser. No. 12/909,606, filed Oct. 21,2010 and issued as U.S. Pat. No. 7,993,354 Aug. 9, 2011, which in turnclaims the benefit of priority of U.S. Patent Application Ser. No.61/388,648, filed Oct. 1, 2010. This application is also related toInternational Application No. PCT/US2009/006212 filed Nov. 20, 2009,which in turn claims priority to U.S. Provisional Application Ser. No.61/200,180, filed Nov. 25, 2008. This application is also related toU.S. patent application Ser. No. 11/231,135, filed Sep. 20, 2005, whichin turn claims the benefit of priority to U.S. Provisional ApplicationSer. No. 60/611,362, filed Sep. 20, 2004. This patent application isalso related to International Application No. PCT/US2008/06674 filed May23, 2008, which in turn claims priority to U.S. Provisional ApplicationSer. No. 60/939,887, filed May 24, 2007. This patent application is alsorelated to U.S. patent application Ser. No. 12/175,442, filed Jul. 17,2008. Each of the aforementioned applications is incorporated byreference herein in its entirety.

FIELD

The embodiments disclosed herein relate to a medical device for suturingtissue, and more particularly to a device for the manipulation andcontrol of a suturing needle during minimally invasive suturing, methodsfor making such a device and methods for using such a device forsuturing tissue.

BACKGROUND

Minimally invasive surgery (MIS) has allowed physicians to carry outmany surgical procedures with less pain and disability thanconventional, open surgery. Unlike conventional open surgery, where thesurgical site is readily accessible through a large incision, enablingthe surgeon to easily visualize and manipulate both tissue andinstruments, MIS requires the surgeon to operate remotely by insertingand manipulating instruments through small punctures (“keyhole surgery”)or through natural orifices, including for example the vagina, theesophagus, or the anus.

In MIS, a small puncture is typically made in the body. Medicalinstruments are then inserted through a cannula. A cannula has a smallinside diameter, typically 5-10 millimeters (mm), and sometimes up to 20millimeters (mm) or more. A number of such cannulas may be inserted intothe body for any given operation. Minimally invasive surgicalinstruments are necessarily smaller, and are also generally longer andtherefore are more difficult to manipulate with precision.

Perhaps the most problematic surgical task in MIS is suturing. Suturingrequires coordinated manipulation with both hands of small needles andsutures that are difficult to visualize (particularly when onlyindirect, two-dimensional video imaging is available) as well as theseveral instruments (including needle-drivers and pick-up forceps)ordinarily used to suture by hand. In an environment characterized bylimited space, limited visualization, and limited mobility, manysurgeons find minimally invasive suturing by hand an extremelydifficult, often virtually impossible, surgical task.

In the preferred method of suturing by hand, a grasping forceps (“needledriver”) is held by the surgeon and is used to grip a curved needle nearthe needle's tail. Pronation of the surgeon's wrist drives the needleinto the tissue. When the point of the curved needle emerges from thetissue, the surgeon releases the needle from the grip of the needledriver and grasps the point with another forceps (“pick-ups”). Thesurgeon then pulls the curved needle by the needle point, preferably ina circular path following the arc of the needle's curvature to followthe most atraumatic path through the tissue, until the entire length ofthe needle has exited the tissue. Each time a stitch is placed, thecurved needle is thus driven around in a complete circular arc.Individual (interrupted) stitches are placed by tying off the suturefollowing placement of each stitch. Running (continuous) stitches areplaced by repeatedly driving the curved needle in a complete circulararc repeatedly until the desired length of suture and number of stitcheshas been placed. In order to place additional interrupted or continuousstitches, the surgeon must let go of the point of the needle andre-grasp the needle near the needle's tail.

In the manual suturing technique described above, the direct handling ofthe needle can result in accidental needle pricks through a surgeon ornurse's gloves, posing a potential risk of infection for the surgeon,nurse, staff, and patient, or cause the needle to become contaminatedwith pathogenic bacteria that can cause onset of infection at the siteof the sutures. There is also a risk of the needle penetrating internalorgans or vessels and causing a serious, and often fatal infection.

Various devices for suturing for MIS are described in U.S. Pat. No.5,643,295 entitled “Methods and Apparatus for Suturing Tissue”; U.S.Pat. No. 5,665,096 entitled “Needle Driving Apparatus and Methods ofSuturing Tissue”; U.S. Pat. No. 5,665,109 entitled “Methods andApparatus for Suturing Tissue”; U.S. Pat. No. 5,759,188 entitled“Suturing Instrument with Rotatably Mounted Needle Driver and Catcher”;U.S. Pat. No. 5,860,992 entitled “Endoscopic Suturing Devices andMethods”; U.S. Pat. No. 5,954,733 entitled “Suturing Instrument withRotatably Mounted Needle Driver and Catcher”; U.S. Pat. No. 6,719,763entitled “Endoscopic Suturing Device”; and U.S. Pat. No. 6,755,843entitled “Endoscopic Suturing Device”, all of which are incorporated byreference in their entireties for the teachings therein.

Assignees' U.S. Pat. No. 5,437,681, U.S. Pat. No. 5,540,705 and U.S.Pat. No. 6,923,819 disclose a suturing device with thread managementcomprising a protective cartridge, suturing needle and needle rotationdrive, the disclosures of which are hereby incorporated by reference.The devices described in the above-mentioned patents and patentapplication comprise a mechanism for driving a protected needle however,the needle is rotated about an axis that is parallel to the axis of thedevice. In addition, the orientation and size of the suturing devicemakes it difficult to visualize and cumbersome to use for MIS.

Therefore, there remains a need in the art for a minimally invasivesuturing device that is easily manipulated within the small diameter ofthe cannula; functions in an environment characterized by limited space,limited visualization, and limited mobility; mimics the preferred methodof suturing used by surgeons; permits the surgeon to secure and tieknots quickly and with controlled tension; places continuous stitches;and protects users from accidental needle sticks during needle handling,as well as internal organs and vessels from inadvertent needle-pricks.

SUMMARY

Devices and methods for minimally invasive suturing of tissue internalto a body are disclosed herein.

According to aspects illustrated herein, there is provided a medicaldevice for closing openings internal to a patient's body, which closelyemulates or replicates the manual suturing actions carried out by asurgeon. The device offers several advantages over conventional methodsused by surgeons for suturing tissue during minimally invasive surgeryin that the device provides a hand-held suturing instrument thatrequires no external motive source. The presently disclosed embodimentsprovide relative ease of operation for the surgeon with only one hand.

According to aspects illustrated herein, a suture head assembly may beremovably attached to an actuator mechanism of the suturing device. Thediameter of the device is small enough to fit into a 5 mm cannula insome embodiments, thus making the device extremely easy to maneuver, aswell as suture, during endoscopic or other MIS procedures. In surgicalprocedures, it is desirable to make as few incisions as possible, andfor those incisions to be as small as possible. As such, devices withreduced profile are highly advantageous. Also, the suture head assemblyof the device can be laterally articulated to the left of center, to theright of center, up, and down, once inside the cannula, which is idealfor use in the course of endoscopic surgery, including laparoscopy,thoracoscopy and arthroscopy, as well as other less-invasive surgicalprocedures.

Devices of the present disclosed embodiments closely emulate orreplicate the manual suturing actions carried out by a surgeon. Forexample, during manual suturing by hand, the needle is held in forcepsand travels in a circular arc with no obstructions anywhere in theinterior of the arc. The design of the suturing devices of the presentdisclosed embodiments allows for a lack of obstruction in the center ofthe arc of the needle during suturing. In other words, there is no hubat the center of the circular arc of the suturing needle. The entirearea within the circular arc of the needle is unobstructed. This allowsfor the user to have better visualization during operation, unlike thepresent mechanical suturing methods, while maintaining control overneedle movement.

A benefit provided by suturing devices of the presently disclosedembodiments is that the devices enable maneuvering a suturing materialthrough a tissue incision in a manner substantially similar to the way asurgeon would do so by hand. In particular, some embodiments of thesuturing device first push a suturing needle from the tail of the needleand drives the point of the needle through the tissue. The device thenpicks up the point of the needle that passed through the tissue, andpulls the remainder of the suturing needle and the suture attached tothe suturing needle through the tissue. The suturing needle thusconsistently follows the arc of the needle's own curve, which is thepreferred method of suturing, in the most atraumatic way of passing aneedle through tissue. A benefit provided by the suturing device of thepresently disclosed embodiments is the ability of the suturing needle topull the suturing thread entirely through the tissue segments beingclosed, following each stitch. When using the suturing device of thepresently disclosed embodiments, no ancillary instruments or tools suchas needle holders, pick-up forceps or the like are needed to completethe stitch. A forceps or grasping instrument can be used to tighten theknots.

According to aspects illustrated herein, there is provided an embodimentof a suturing device that includes a suturing needle that is protectedby a housing, the suturing needle is not exposed to or handled directlyby the user, thereby preventing inadvertent needle sticks. Theconfiguration of the suturing device of the presently disclosedembodiments also protects against inadvertent penetration of internalorgans or vessels by the needle, since the housing acts as a shieldbetween the organs and the needle.

In one embodiment, a suturing device is provided having a suturing head.The suturing head includes a housing defining at least one passagetherein and a deployable needle track. The deployable needle track isdisposed in the housing, and the needle track is adapted and configuredto be deployed, or expanded from a stored or contracted conditionwherein the needle track is essentially disposed within the housing toan expanded, or deployed condition wherein the needle track extendsoutwardly from the housing to form an arcuate needle track. The devicefurther includes an arcuate or circular needle disposed in thedeployable needle track, the needle having a first end, a second end,and a generally toroidal body. The device further includes a drive foradvancing the needle about a 360° path about the needle track when thedeployable needle track is in a deployed condition. The drive is adaptedand configured to advance the needle in multiple 360° revolutions aboutthe needle track when the deployable or expandable needle track is in adeployed or expanded condition without removing the needle from theneedle track. The drive selectively engages with and disengages from theneedle to advance the needle about a 360° rotation.

In accordance with further aspects, the housing of the suturing devicecan be generally cylindrical, and have an outer diameter of about 5.0mm. The circular path of the needle track can have a diameter of about10 mm. If desired, the needle can have a non-circular cross-section.Preferably, the device further includes means for deploying the needletrack from the stored condition to the deployed condition. The needletrack can occupy about 270° of the 360° needle path when the needletrack is deployed. It will be appreciated however that the presentdisclosure is directed to a device having a deployable, or, angularlyexpandable, needle track that can expand to a final extent that isgreater or less than 270°, such as in increments of one degree. Forexample, a needle track can be provided that expands from about 180° toabout 190°, about 200°, about 210°, about 220°, about 230°, about 240°,about 250°, about 260°, about 270°, about 280°, about 290°, about 300°,about 310°, about 320°, or about 300°, among others. For example,depending on the diameter of the device and the dimensions of the needletrack, it may only be necessary to have guides that increase the angularextent of the needle track by about 10°, about 20°, about 30°, about40°, about 50°, about 60°, about 70°, about 80°, about 90°, about 100°,about 110°, about 120°, about 130°, about 140°, about 150°, or about160° from the undeployed (unexpanded) configuration to the deployed(expanded) configuration. The drive can include an elongate flexiblemember that reciprocates along a longitudinal axis of the device. Thedrive can engage with and advance the needle along the needle track whenthe elongate flexible member is advanced proximally with respect to thehousing. The needle can include first and second notches along an innerface of the needle for engaging an antirotate mechanism disposed on atleast one of the housing and the deployable needle track. The needle canfurther include a notch on a top face of the needle for engaging aportion of the drive, wherein the notch on the top face of the needleintersects one of the notches disposed on the inner face of the needle.

In accordance with a preferred embodiment, the deployable needle trackincludes at least one arcuate guide that is adapted to be deployed fromthe housing along an arcuate path. Preferably, the deployable needletrack includes a pair of arcuate guides that are adapted to be deployedfrom the housing along an arcuate path. The pair of arcuate guides arepreferably deployed from the housing along the arcuate path by pullingin a first pair of pull wires, wherein one pull wire is attached to eachguide. The pair of guides are further preferably adapted and configuredto be retracted into the housing by pulling in a second pair of pullwires, wherein one pull wire in the second pair of pull wires isattached to each guide. The first pair of pull wires is preferablyconnected to the second pair of pull wires to make a pair of continuousmechanical loops, wherein the loops are connected at a distal end to theguides, and at a proximal end to a pair of handles, wherein movement ofthe handles results in movement of the guides.

The disclosure also provides a suturing needle having an arcuate bodywith a leading tip and a trailing end, wherein the arcuate body definesa first notch along an inner radial region needle and a second notchhaving a projection that lies within a plane that is defined by acentral curved axis of the needle, and further wherein the first notchand second notch intersect. If desired, the needle can further includesa generally square cross-section. The needle body can include a portionwith a round cross section that separates a main portion of the needlewith a generally square cross section from a tail portion with agenerally square cross section. The needle can further define a thirdnotch in the needle proximate its trailing end for receiving a portionof a drive pawl. Moreover, the needle can define an arcuate keel alongits length to stabilize its movement in the suturing device.

According to aspects illustrated herein, there is provided a method forsuturing tissue during minimally invasive surgery that includesinserting a distal end of a suturing device having a suturing needlewith a pointed end into a body; positioning the suturing needle to spana plurality of separated tissue segments; activating an actuator a firsttime causing the pointed end of the suturing needle to extend beyond aprotective housing of a cartridge to engage the plurality of separatedtissue segments; and activating the actuator a second time to cause thesuturing needle to complete a revolution and pull a suture extendingfrom the suturing needle through the plurality of separated tissuesegments to form a stitch.

In accordance with a further aspect, a suturing device having a suturinghead is provided. The suturing head includes a housing defining at leastone passage therein, the housing having a proximal end, a distal end anda peripheral side joining the proximal and distal ends. The head furtherincludes a deployable needle track disposed at least partially withinthe housing, the needle track being adapted and configured to bedeployed from a stored condition wherein the needle track is essentiallydisposed within the housing and has an angular extent of about 180° to adeployed condition wherein the needle track has an angular extent inexcess of 180° and extends outwardly from the peripheral side of thehousing to form an arcuate needle track that lies in a plane that isparallel to a longitudinal axis of the housing. Preferably, the needletrack is angularly expandable along a circular path that defines thepath of travel of the needle such that the track expands angularly aboutthe circular path from a contracted condition to an expanded condition.The suturing head further includes an arcuate needle disposed in thedeployable needle track, the needle having a first end, a second end,and a generally toroidal body. The suturing head further includes adrive for advancing the needle in multiple 360° revolutions about theneedle track when the deployable needle track is in a deployedcondition, wherein the drive selectively engages with and disengagesfrom the needle to advance the needle about a 360° rotation.

In accordance with a further aspect, housing is generally cylindrical,and has a diameter of about 5.0 mm and the path of the needle track hasa diameter of about 10 mm. However, it will be appreciated that thediameter can be larger or smaller as desired. The needle can have asubstantially circular cross section, a circular cross section, anon-circular cross-section, a square or triangular cross section, or mayhave a cross section that varies along its length that transitions fromone shape to another, such as from a square to a circle to a square. Thedevice preferably further includes means for deploying the needle trackfrom the stored condition to the deployed condition. The needle trackpreferably occupies about 270° of a 360° needle path when the needletrack is deployed, but the angular extent of the track can be more orless than 270°, as desired, in one degree increments, for example.

In accordance with a further aspect, the drive preferably includes anelongate flexible member that reciprocates along a longitudinal axis ofthe device. The drive preferably engages with and advances the needlealong the needle track when the elongate flexible member is advancedproximally with respect to the housing. The deployable needle trackpreferably includes at least one arcuate guide that is adapted to bedeployed from the housing along an arcuate path. The deployable needletrack preferably includes a pair of arcuate guides that are adapted tobe deployed from the housing along an arcuate path. The pair of arcuateguides are preferably deployed from the housing along the arcuate pathby pulling in a first pair of pull wires, wherein one pull wire isattached to each guide. The pair of arcuate guides is preferably adaptedand configured to be retracted into the housing by pulling in a secondpair of pull wires, wherein one pull wire in the second pair of pullwires is attached to each guide. The first pair of pull wires ispreferably connected to the second pair of pull wires to make a pair ofcontinuous mechanical loops, wherein the loops are connected at a distalend to the guides, and at a proximal end to a pair of handles, whereinmovement of the handles results in movement of the guides.

In another embodiment, a suturing device is provided having a suturinghead. The suturing head includes an elongate housing having a proximalend, a distal end and a peripheral side joining the proximal and distalends, wherein the housing defines a longitudinal axis from its proximalend to its distal end. The suturing head further includes a deployableneedle track disposed at least partially within the housing, at least aportion of the needle track being adapted and configured to be deployedalong an arcuate path from a undeployed condition wherein the needletrack has an arcuate extent of about 180 degrees and is essentiallydisposed within the housing to a deployed condition wherein the needletrack has an arcuate extent in excess of 180 degrees, and wherein theneedle track lies in a plane that is parallel to a longitudinal axis ofthe housing. The suturing head further includes an arcuate needledisposed in the deployable needle track, the needle having a first end,a second end, and a generally toroidal body. The suturing head alsoincludes a drive for advancing the needle in multiple 360° revolutionsabout the needle track when the deployable needle track is in a deployedcondition, wherein the drive selectively engages with and disengagesfrom the needle to advance the needle about a 360° rotation.

In accordance with a further aspect, the housing can be generallycylindrical or rectilinear, as desired. The deployable or expandableneedle track can include one or more arcuate guides that are adapted tobe deployed from the housing along an arcuate path. The deployable orexpandable needle track can include a pair of arcuate guides that areadapted to be deployed from the housing along an arcuate path.Accordingly, a pair of arcuate guides can be deployed from the housingalong the arcuate path by pulling on a first pair of pull wires, whereinone pull wire is attached to each guide. In one embodiment, thedeployable or expandable needle track occupies about 270° of a 360°needle path when the needle track is in the expanded condition, but theangular extent of the track can be more or less than 270°, as desired,in one degree increments, for example.

These and other advantages of the presently disclosed embodiments areillustrated through the embodiments described hereinafter. The presentlydisclosed embodiments accordingly comprise the features of construction,combination of elements and arrangement of parts that will beexemplified in the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The presently disclosed embodiments will be further explained withreference to the attached drawings, wherein like structures are referredto by like numerals throughout the several views. The drawings shown arenot necessarily to scale, with emphasis instead generally being placedupon illustrating the principles of the presently disclosed embodiments,wherein:

FIGS. 1-3 generally depict a suturing device made in accordance with thepresent disclosure.

FIGS. 4-32 and 47(A)-47(D) illustrate aspects of a first embodiment of asuturing head of a suturing device made in accordance with the presentdisclosure.

FIGS. 33-37 illustrate aspects of an embodiment of a needle loader madein accordance with the present disclosure.

FIGS. 38-40 illustrate aspects of a first embodiment of a suturingneedle made in accordance with the present disclosure.

FIGS. 41-44 illustrate aspects of a second embodiment of a suturingneedle made in accordance with the present disclosure.

FIG. 45 illustrates aspects of a third embodiment of a suturing needlemade in accordance with the present disclosure.

FIG. 46 illustrates aspects of a fourth embodiment of a suturing needlemade in accordance with the present disclosure.

FIGS. 47(E)-55 illustrate aspects of a second embodiment of a suturinghead of a suturing device made in accordance with the presentdisclosure.

FIGS. 56-59 illustrate aspects of an intermediate region of the suturingdevice illustrated in FIGS. 1-3.

FIGS. 60-122 illustrate aspects of a handle portion of the suturingdevice illustrated in FIGS. 1-3.

FIGS. 123-131 illustrate operation of the suturing head of FIGS. 4-32and 47(A)-47(D).

While the drawings set forth presently disclosed embodiments, otherembodiments are also contemplated, as noted in the discussion. Thisdisclosure presents illustrative embodiments by way of representationand not limitation. Numerous other modifications and embodiments can bedevised by those skilled in the art which fall within the scope andspirit of the principles of the presently disclosed embodiments.

DETAILED DESCRIPTION

Reference will now be made in detail to the present preferredembodiments of the disclosure, examples of which are illustrated in theaccompanying drawings. The method and corresponding steps of thedisclosed embodiments will be described in conjunction with the detaileddescription of the system.

Broadly speaking, the disclosure provides embodiments of suturingdevices having features that permit the device to be constructed on asmaller scale and having a smaller profile than embodiments discussed inthe prior art and in patent applications incorporated herein byreference. In particular, embodiments made in accordance with thepresent disclosure have been constructed that are adapted and configuredto fit through a 5 mm trocar. Advantageously, the disclosed embodimentsstill use a comparatively large suturing needle, thereby permittingsubstantial tissue capture during operation, resulting in effectivesuturing.

For purposes of illustration and not limitation, as embodied herein, anexemplary embodiment of a suturing device 1000 is illustrated in FIG. 1.Device 1000 includes three regions, including a suture head 100, anintermediate region 500, and a handle 600. Each of these regions isdiscussed in detail below. FIGS. 2-3 illustrate device 1000 with certainportions removed. In particular, FIG. 2 illustrates device 1000 with aneedle loader removed (discussed in further detail below), while FIG. 3illustrates device 1000 with certain portions of the handle housingremoved.

For purposes of illustration, and not limitation, suture head 100,separated from the remainder of device 1000, is illustrated in FIG. 4.Suture head 100 includes a proximal end 102, a distal end 104, and isformed by the cooperation of three main housing components (106, 108,112) that define a gap 110 for receiving tissue of a patient to besutured together. Suture head 100 is adapted and configured to direct asemi-circular needle (300, 350, 400) about a semicircular track andacross gap 110 to form a series of sutures through tissue to be sutured.

Prior to advancing needle across gap 110, suture head 100 must beconverted from a delivery configuration to a deployed configuration. Asillustrated in FIG. 4 and FIG. 5, suture head 100 is initially providedin a compact form having a predetermined transverse dimension, ordiameter, φ. This transverse dimension, φ, can be any desired dimension,and is preferably about 5 millimeters. In particular, the dimension φ ispreferably selected so that suture head 100 can pass through a standard5 mm trocar into a patient's abdomen, for example, during a laparoscopicsurgical procedure. FIG. 5 shows suture head 100 from the opposite angleas compared to FIG. 4, including pivot boss 114, which mates withintermediate portion 500 of device 1000.

Suture head 100 is illustrated in deployed configuration in FIG. 6. Asillustrated in FIG. 6, in a deployed configuration, proximal guide 120and distal guide 130 are moved outwardly from their nested positiondefined by housing components 106, 108, discussed in further detailbelow. When deployed as in FIG. 6, guides 120, 130 define a circularneedle path or track 140 that lies in a plane P that is parallel to alongitudinal axis X of device 1000. In addition, as illustrated, leadingtip 302 of needle 300 is advanced slightly by virtue of being draggedalong by virtue of a pawl 125 in proximal guide 120 engaging a notch 306disposed along an interior surface of needle 300, discussed in detailbelow.

After guides 120, 130 are in a deployed condition and needle track 140is defined, needle 300 can then be advanced through track by advancingpawl 160 to a distal extremity along its path of reciprocation. FIG. 7illustrates needle 300 spanning the gap 110, wherein needle 300, beingabout 180° in arcuate extent, is essentially located outside of theenclosure defined by housing segments 106, 108, 112.

FIGS. 8-10 illustrate the functionality of suture head 110 from theopposite side of the head. FIG. 8 illustrates suture head 100 in adelivery configuration with the guides 120, 130 retracted. As can beseen, engagement pawl 160 is withdrawn to a position proximal to theneedle 300, and the trailing end 304 of needle 300 is visible. FIG. 9illustrates suture head in a deployed configuration wherein guides 120,130 are deployed. As seen in FIG. 9, distal guide 130 defines an arcuaterecess 135 that receives the pawl 160 at the distal extremity of itsreciprocating movement, best observed in FIG. 10. As is evident fromFIG. 10, notch 158 in drive member 150 is advanced in a distal directionas is pawl 160.

FIGS. 11(A)-11(D) illustrate the structure of the engagement pawl 160.Pawl 160 includes a housing 166 attached (e.g., welded) to the distalend 154 of drive member 150. Housing 166 is preferably a metallictubular structure, and houses a pawl spring 164 biased between a movablepin 168 and cap portion 162. Cap 162 is preferably attached to housing166, such as be welding.

FIG. 12 illustrates suture head 100 with cover portion 106 removed,revealing the reciprocating guide path followed by drive member 150 andpawl 160, as well as guides 120, 130. Guides 120, 130 are advanced fromthe delivery configuration to the deployed configuration by fouradvancement wires, cables or filaments, 172, 174, 176, 178 that aredirected around a series of bosses in housing portion 106, discussedbelow. In particular, each guide 120, 130 includes crimps 102 a, 120 b,130 a, 130 b that integrally form a end of each of the guides 120, 130.Each crimp includes passages formed therein for receiving an end ofwires 172-178. Wires 172-178 can take any suitable form, most preferablymulti-strand 300 series Stainless Steel cables 0.009″ in diameter. Theseends are then crimped, adhered or otherwise attached to the crimps. Thenby applying tension to one wire in each pair attached to each guide, theguides 120, 130 are pulled into or out of the suture head 100.

FIG. 13 illustrates the guides 120, 130 in a deployed condition and doesnot display wires 172-178 simply for purposes of clarity. FIG. 14illustrates drive member 150 with pawl 160 at the full distal extent ofits travel, riding within groove 135 in the side of guide 130. Theelevation 130 e of wall 130 d can be increased and can be thickened tocoincide with groove 135 to provide an enhanced bearing surface for pawl160. Stops (not shown) are preferably provided in the form of raisedsurfaces on guides 120, 130 and the housing components to help preventguides 120, 130 from falling out of suture head.

As is also evident, groove 125 in the side of guide 120 becomesaccessible for the passage of pawl when the guides are in a deployedcondition. As illustrated in FIG. 14, guide 150 traverses an arcuatepath along guides and follows the path of the needle. FIG. 15illustrates the spatial relationship of drive member 150 with respect toneedle with other device components removed. FIG. 16 illustrates therelative positions of needle 300 with respect to antirotate springs 115and drive pin 168 housed within pawl 160. FIG. 17 illustrates drive pin168 in detail, wherein pin 168 includes a distal face 168 a thatcontacts a body of the needle, a circumferential generally cylindricalface 168 b, the distal extremity of which also contacts a surface of anotch in needle 100, or the distal end 304 of needle, a proximal face168 d that contacts pawl spring 164, an enlarged head portion 168 c, anda circumferential distal face 168 e that contacts with a narrowedportion of the housing 166 of pawl 160 that prevents pin 168 fromfalling out of housing 166.

FIGS. 18-21 are additional views of suture head 100 showing aprogressive removal of components. FIG. 18 shows the suture head 100 intact, while FIGS. 19-20 shows the positioning of bosses 106 a, 106 b,106 c on housing portion 106 that define bearing points for guide cables172, 174, 176, 178 (not shown). Spacers 106 d may also be provided tomaintain a desired distance between housing components 106, 108 topermit the movement of components within suture head 100, and can alsoact as bearing surfaces for wires 176, 178 (FIG. 29). FIGS. 20-21illustrate removal of guard 109 which provides inner support for guides120, 130 to bear against. Guides 120, 130 ride in arcuate channelsdefined by the cooperation of components 106, 108 and 109.

FIG. 22 illustrates proximal and distal guides 120, 130 in the samespatial relationship as in FIG. 21. Views of the proximal guide 120 aredepicted in FIGS. 23(A)-23(B). Guides 120, 130 are preferably made froma metallic material by assembling a series of metallic subcomponents,such as by laser welding, and are unitary and integral once assembled.Guides can be thought of as having a “top” face that faces the drivemember 150, and a bottom “face” that faces housing portion 108. Proximalguide 120 defines a curved channel 125 in the top face 122 thereof.Proximal guide 120 further defines a lower face 124, having a groove 124b defined therein, an inner face 126 that bears against the innersurface of guard 109 and an outer face 128 that bears against housingcomponents 106, 108. As illustrated in FIGS. 24(A)-24(B), distal guide130 defines a curved channel 135 in the top face 132 thereof for guidingthe pawl 160. Distal guide 130 further defines a lower face 134, havinga groove 134 b defined therein, an inner face 136 that bears against theinner surface of guard 109 and an outer face 138 that bears againsthousing components 106, 108.

FIGS. 25-32 illustrate the cooperation between wires/filaments 172-178and guides 120, 130. As shown in these figures, wires/filaments 172,174, 176 and 178 cooperate with bosses 106 a, 106 b, 106 c and the othercomponents of suture head 100 to permit guides 120, 130 to beselectively advanced and retracted. Wire 178 terminates in crimp 130 bof guide 130. Applying tension to wire 178, which wraps around boss 106a (FIG. 28) results in guide 120 being advanced out of the suture head100. Conversely, applying tension to wire 176, which terminates in crimp130 a of guide 130 (FIG. 30) causes guide 130 to be retracted intosuture head 100. Similarly, applying tension to wire 172, which wrapsaround boss 106 c and is attached to guide 120 at crimp 120 b, causesguide 120 to be advanced out of suture head, while applying tension towire 174, which wraps around boss 106 c in a direction opposite to wire172, pulls at the attachment point at crimp 120 a, causing the guide 120to be withdrawn back into the housing.

FIGS. 33-37 illustrate an embodiment of a needle loader 180 that isconfigured for loading a suturing needle (300, 350, 400) into suturehead 100. Needle loader 180 has two main components, including a mainbody portion 182 and an advancement portion 184. Pin 184 a ofadvancement portion is received in opening 182 a of main body portion182. Main body portion 182 defines a groove 182 f for receiving asuturing needle (300, 350, 400). Main body portion 182 includes acentral portion 182 d and clip portions 182 c, 182 e that fit oversuture head 100. If desired, clip portions 182 c, 182 e may be adaptedto snap fit over suture head 100. A distal stop plate 182 b is providedto facilitate axial alignment between loader 180 and suture head 100.Advancement portion 184 rotates within opening 182 a of main bodyportion 182, and further includes a needle pushing arm 186. Inoperation, a needle is situated within track 184 f with suturingmaterial attached to the trailing end, as discussed herein. The loader180 is then snapped onto suture head. Arm 186 is preferably situated atthis time proximate the trailing end of the needle. Arm 186 is thenrotated such that needle (300, 350, 400) is advanced into the needletrack 140. If needed, needle (300, 350, 400) can be advanced back intothe needle loader 180, by virtue of the fact that arm 186 is dimensionedto pass through the grooves 124 b, 134 b of proximal guide 120 anddistal guide 130, respectively.

FIGS. 38-40 illustrate a first embodiment of a suturing needle 300.Needle 300 includes an arcuate body defined by a leading end 302, atrailing end 304 and a generally toroidal surface 305. Needle 300includes a plurality of notches 306, 308, 310 formed therein, as well asan opening 312 in trailing end 304 for receiving an end of a length ofsuturing material 312 a. Notches 306, 308 are located on an inner radialregion 322 of needle, while notch 310 has a projection that lies withina plane P′ that is defined by the central curved axis X′ of the needle.Notch 310 includes a first portion 310 a that is generally perpendicularto the plane P′ and a portion 310 b that generally lies in plane P′, anda sloped portion 310 c. The notches 306, 308 have projections that aregenerally perpendicular to the plane P′. Notches 308, 306 have firstportions 306 a, 308 a that are generally parallel to a cross section ofthe needle in that location, and sloped portions 306 b, 308 b that areangled (such as by an angle of 60 degrees) with respect to portions 306a, 308 a. Notches 308, 310 intersect to facilitate the function of theparticular embodiments of suturing head 100, 100′ described herein.

FIGS. 41-44 illustrate a second embodiment of a suturing needle 350.Needle 350 includes an arcuate body defined by a leading end 352, atrailing end 354 and a generally toroidal surface 355. Needle 350includes a plurality of notches 356, 358, 360 formed therein, as well asan opening 362 in trailing end 354 for receiving an end of a length ofsuturing material. Notches 356, 358 are located on an inner radialregion 372 of needle, while notch 360 has a projection that lies withina plane P′ that is defined by the central curved axis X′ of the needle.Notch 360 includes a first portion 360 a that is generally perpendicularto the plane P′ and a portion 360 b that generally lies in plane P′, anda sloped portion 360 c. The notches 356, 358 have projections that aregenerally perpendicular to the plane P′. Notches 358, 356 have firstportions 356 a, 358 a that are generally parallel to a cross section ofthe needle in that location, and sloped portions 356 b, 358 b that areangled (such as by an angle of 60 degrees) with respect to portions 356a, 358 a. Notches 358, 360 intersect to facilitate the function of theparticular embodiments of suturing head 100, 100′ described herein.Needle 350 further includes a generally square cross-section having arounded portion 366 and a tail portion 364, also having a round crosssection. Stated another way, the needle body includes a portion with around cross section 366 that separates a main portion of the needle witha generally square cross section from a tail portion 364 with agenerally square cross section. It is believed that using a needle witha square cross section helps the needle 350 cross the gap 110 of suturehead and re-enter suture head with superior alignment as compared toneedle 300.

FIG. 45 illustrates a third embodiment of a suturing needle 400. Needle400 includes an arcuate body defined by a leading end 402, a trailingend 404 and a generally toroidal surface 405. Needle 400 includes aplurality of notches 406, 408, 410 formed therein, as well as an opening412 in trailing end 404 for receiving an end of a length of suturingmaterial. Notches 406, 408 are located on an inner radial region 422 ofneedle, while notch 410 has a projection that lies within a plane P′that is defined by the central curved axis X′ of the needle. The notches406, 408, 410 are generally similar to those described with respect toneedle 300. The principal difference between needles 300, 400 are theaddition of an additional notch 415 cut into the needle proximate itstrailing end 404. Notch 415 has a projection in the plane P′ and isshaped to receive the housing 166 of the pawl 160. It is believed thatusing a needle with notch 415 helps the needle 400 cross the gap 110 ofsuture head and re-enter suture head with superior alignment as comparedto needle 300.

FIG. 46 illustrates a fourth embodiment of a suturing needle 450. Needle450 is essentially the same as needle 300, except that it furtherincludes an arcuate keel 475, or raised surface, along its length. Keel475 is adapted and configured to ride in grooves 124 b, 134 b of guides120, 130 to stabilize the needle 450 as it crosses the gap 110 of suturehead and re-enters suture head with superior alignment as compared toneedle 300.

FIGS. 47(F)-55 illustrate aspects of an alternative embodiment of asuture head 100′ made in accordance with the disclosure. The principaldifference between suture head 100 and suture head 100′ lies in the pathof travel of the drive element 150.

Embodiment 100 of suture head includes a drive member 150 that defines anarrowed, or notched region 158, as illustrated in FIG. 12, for example.In operation, notched region 158 is located to coincide with bosses106W, 108W (FIGS. 47(A)-47(D)) when pawl 160 is located at the distalextremity of its range of motion within groove 135 of distal guide 130.When in this position, drive member 150 extends into groove 125 ofproximal guide 120 (FIG. 14). However, as soon as tension is thenapplied to bring pawl 160 (and needle 300) proximally along the needletrack, the narrowed region 158 of drive member 150 slips past bosses106W, 108W, so that pawl 160 will travel up lower leg of passage 106Twhen moving proximally until it passes boss 106W and emerges from thepassage, ready to begin another cycle. Stated another way, bosses 106W,108W result in a passageway between them that permits narrowed region158 to slip through, but not the rest of member 150 or pawl 160. Thus,narrowed region 158 permits the drive member 150 to travel along anupper path above bosses 106W, 108W when advancing distally, and slippast bosses 106W, 108W when region 158 aligns with the bosses, thuspermitting drive member 150 and pawl 160 to move proximally along alower path below bosses 106W, 108W. Housing portion 112 is illustratedin FIG. 47(E).

Accordingly, it can be appreciated that drive member 150 should ideallybe metallic. Preferably, member 150 is made from hardened stainlesssteel that has been heat treated to HR 900, and may have a chromiumcoating, such as an Armoloy ME 92® coating commercially available fromME-92® West/Armoloy® of Illinois, 118 Simonds Avenue, DeKalb, Ill.60115, (815) 758-6691. Preferably, member 150 is 17-7 PH Stainlesssteel, condition “C” that is then hardened to condition CH900, and thencoated with a ME 92® coating. Preferably, the ME-92® coating is appliedafter 900 Heat Treatment. The sequence of operations in manufacturingmember 150 includes providing 17-7 PH strip stock material that ismachined to size by any number of known methods (e.g., electricaldischarge machining (“EDM”), shearing, milling, etc.). The drive ribbonis heat treated, and then cleaned to remove heat treatment surfaceoxidation, and the ME-92® coating is then applied. By way of furtherexample, 17-7PH condition “A” material can be heat treated to RH950. Inother embodiments, the drive member 150 can be made, for example, fromshape memory material such as nickel-titanium alloys sold under thetrade name of NITINOL® and the like. In another embodiment, member 150is made from a polymeric material. In one aspect, member 150 can includepolyethylene terephthalate material or nylon material of high strength.If desired, a laminate of plastic and metal materials or multiplematerials can be used. By way of further example, member 150 can becomprised of a bundle of wires or filaments, a single wire or filament,or any material in any configuration that permits driving the needlearound the needle track.

The other components of suture head 100 including the needle (300, etc.)are preferably formed by metal injection molding (“MIM”) techniques, asare known in the art from various materials, preferably stainless steel.In accordance with a preferred embodiment, 17-4 PH stainless steel alloyis preferably used. Device 1000 is preferably a disposable device, andhandle components are preferably made from injection molded plasticwherever desirable.

A further embodiment of a suture head 100′ is set forth in FIGS.47(F)-55. The principal difference between suture head 100′ and suturehead 100 is that the drive member 150 in suture head 100′ follows asingle path during reciprocation, in contrast with the alternating pathof embodiment 100. FIG. 47(F) illustrates suture head 100′ including aneedle 300 with guides 120′, 130′ in a deployed configuration. Guides120′ 130′ are only partially represented and are not depicted includingcrimps at their extremities for mating with deployment or retractioncables as with embodiment 100 discussed earlier. Suture head 100′defines a guide path 153′ between housing components 106′, 112′ (FIG.48), similar to the manner in which suture head 100 defines a guide pathbetween housing components 106 and 112 (FIG. 21). FIG. 48 furtherillustrates an alternate path 1001 that can be traversed by drive member150′ by modifying components 106′, 112′ by removing material 112 a′ thatacts as a pawl stop and adding material 106′b in component 106′ to actas a new pawl stop. The end result is a different angle of incidence forthe drive member 150.

FIG. 49 illustrates the “left” housing component 108′ from variousangles, while FIGS. 50(A)-50(E) illustrate the “right” housing componentfrom various angles. Apparent from the figures is the path 153′ followedby the drive member 150′ and pawl 160′ (not shown). It will beappreciated that drive member 150′ and pawl 160′ can be substantiallyidentical to embodiments 150, 160, but need not have the notched region158, as a single path for traversal of pawl 160′ is defined bycooperation of housing components 106′, 108′. Guard 109′ is illustratedin FIGS. 51(A)-51(B), and illustrates the location of pawl 115′ thathelps prevent needle (e.g., 300) from moving against the direction ofdesired travel. FIG. 52 illustrates the spatial relationship of guides120′, 130′ with respect to pin face 168 a′ and pawl 160′ in their tworespective locations, for purposes of illustration only. FIGS.53(A)-53(D) illustrate various views of housing portion 112′. FIGS.54-55 illustrate the spatial orientation of guides 120′, 130′ (which aresubstantially identical to guides 120, 130) with respect to pawl 115′and further illustrates guide stops 117′, which help guides 120′, 130′stop in a predetermined location when in an undeployed condition.

FIGS. 56-59 illustrate aspects of the intermediate region 500 of device1000. Intermediate region 500 includes an elongate, preferably metallictube 510 having a proximal end and a distal end 514. Distal end 514 oftube 510 is attached to a knuckle assembly 520, which in turn ispivotally attached at pivot 114 to suture head 110. A pulley 515 islocated at pivot 114 to serve as a bearing surface for adjoinedarticulation cables 532, 534 and cables 532, 534 are preferably affixedto pulley 515 to provide leverage for accomplishing articulation.Articulation cables 532, 534 can take any suitable form, most preferablymulti-strand 300 series Stainless Steel cables that are 0.020″ indiameter. By pulling on one of the articulation cables, the suture head100 will articulate with respect to intermediate region 500 about thepivot 114. Knuckle 520 includes a proximal end 522 and a distal end 524(in the form of a yoke 524 a, 524 b for receiving suture head 100)separated by an intermediate region 526. Intermediate region 526 definesa longitudinal channel 528 therethrough for receiving drive member 150.Preferably, member 150 is attached to a pull rod 151 in this region, andthe cross-sectional profile of channel 528 is adapted to accommodatesuch a geometry, as depicted in the Figures. Openings 523 are alsodefined for receiving members 532, 534. Moreover, openings 525, 527 arealso provided to permit passage of pull wires/cables 172, 174, 176, 178for controlling the movement of guides 120, 130. The proximal end oftubular member 510 is attached to a roticulation mechanism that rotatesthe tube 510 and suture head 100 with respect to a handle 600 of thedevice, discussed below. The distal end 514 a of tube 510 may beextended slightly to provide for tighter control of drive element 150 asit passes into intermediate region 500.

For purposes of illustration, and not limitation, handle 600 of device1000 is illustrated from FIGS. 60-122. Handle 600 includes manycomponents and systems for operating suture head 100, 100′. FIG. 61illustrates a head-on view of handle with tube 510 removed, illustratingroticulation handle 620, wherein relative rotational motion of handle620 with respect to handle 600 will cause the suture head 100, 100′ torotate with respect to handle 600. FIG. 60 depicts a rear view of handle600. FIG. 62 depicts handle with roticulation handle 620 removed, anddepicting proximal cable guide 606, left tube collar 634 and right tubecollar 632. Tube collar portions 632, 634 cooperate to capture theproximal end 512 of tube 510, which can be, for example and notlimitation, a 5 mm nominal outside diameter stainless steel hypotube.Also illustrated is articulation handle 630 that can be used toarticulate suture head 100 about its pivot point as discussed above.Housing 600 includes two main housing halves including a right side 612and a left side 614. FIG. 63 illustrates handle 600 with tube collars632, 634 removed. Proximal cable guide 606 is anchored within hypotube,such as by interference fit. The longitudinal distance along tube 510between the distal disc 606 b of proximal cable guide 606 and cable disc648 (FIGS. 71-72) represents a twist region over which all cables routedthrough tube 510 can rotate and twist about each other when the suturehead is roticulated, or rotated with respect to the handle 600. Thetwist region is preferably between about three and six inches long, mostpreferably about four inches long. In a preferred embodiment, suturehead has a total angular range of motion of about 270 degrees withrespect to handle 600, desirably about 135 degrees in either directionfrom the home position illustrated in the Figures. Detents inroticulation handle 620 (FIG. 64) are adapted and configured to engagewith a pawl 614 g housed in an opening in left handle portion 614 (FIG.79(A)).

Tube collars (FIGS. 66-67) are essentially mirror images of each other(across a vertical centerplane of the device 1000) and cooperate todefine a hollow, generally cylindrical interior for receiving proximalend 512 of tube 510. In particular, lugs 632 a, 634 a are provided tomate with openings 518 near the proximal end 512 of tube 510 (FIG. 69).Tube collars also define radially oriented detents 632 b, 634 b alongtheir proximal faces to mate with raised portions 644 b on the distalface of roticulator plate 644 (FIG. 68). Roticulator plate 644 furtherincludes a proximal portion 644 c having a square cross section forbeing received by the left and right housing side portions 612, 614.

Roticulator plate 644 is received in housing 614 between adjacent ribs614 r (FIG. 70) as is cable disc 648. Cable disc 648 (FIGS. 71-72)defines a circumferential groove 648 b about its periphery for matingwith a rib 614 r as well as an annularly-shaped channel 648 a in itsdistal face for receiving a roticulator spring 646. Spring 646 isadapted and configured to urge roticulator plate into contact withdetents 632 b, 634 b to facilitate stepwise rotational movement. cabledisc 648 further defines a plurality of openings 648 c therethrough topermit passage of cables/wires 172, 174, 176, 178, 532, 534 and 551.

As illustrated in FIGS. 73-74, a cable path guide 650 is provided fordirecting cables 172, 174, 176, 178, 532, 534 through the handle 600. Inparticular, guide 650 provides a first set of guides 654 for guidingcables 172, 174, 176, 178, and a second set of guides, or bosses, 652,654 for directing cables 532, 534 through the handle 600. Grooves 658are provided in guide 650 for receiving ribs 612 r of right housingportion 612 (FIG. 79(D)).

FIGS. 75-76 illustrate a cutaway view of handle 600 wherein righthousing portion 612 has been removed to permit view of interiorcomponents of handle 600. FIG. 75 illustrates trigger 700, or actuator,in a locked position, whereas FIG. 76 illustrates trigger 700 in areleased position wherein the trigger can be depressed, thus advancingneedle (e.g., 300) about needle track 140. As illustrated in FIGS.75-76, handle includes trigger 700, pull cable/ribbon 710, triggerspring capsule 720, trigger return spring 730, pull cable 727, pulley750 and brake handle 800 for preventing articulation knob 810 from beingrotated. As stop surface 614 s is defined in left housing 614 to definea stop point for trigger 700 when trigger 700 is locked. Right housing612 includes a similar stop feature 612 s (FIG. 79(D)). Articulationknob 810 (FIG. 77(E)) includes a handle portion 812, an elongate shaft814 for engaging with brake rotate fitting 830 (FIG. 83), and a distalportion 816 that is preferably threaded for receiving a hex nut 886(FIG. 90). Right and left handle cap portions 616, 618 (FIGS.77(A)-77(D)) are provided with bosses 616 a, 618 a for receiving andsupporting the edges 835 b of brake springs 835 (FIG. 84). Bearingportion 835 a of brake springs 835 bear against brake rotate fittings830, which in turn urges brake rotate fittings 830 against shaft 814 ofknob 810. Portion 814 of knob 810 preferably includes a resilient layeror coating that can grip serrated portion 834 of fittings 830, whereinrotation of the knob 810 causes the fittings 830, and hence cables 532,534 to advance along a proximal-distal direction with respect to device1000, resulting in articulation of suture head 100, 100′. FIG. 78illustrates handle 600 with components 810, 616, 618 removed. FIGS.79(A)-79(D) illustrate inner and outer views of left and right handleportions 612, 614. FIGS. 80-81 illustrate the inner workings of handle600 with both handle portions 612, 614 removed with the trigger 700locked, and released, respectively. FIG. 82 illustrates a close up viewof the inner workings of handle 600, showing the upper brake pad 820removed, fully revealing the positioning of fittings 830 and springs 835with the trigger 700 released. Also illustrated is knuckle pulley 842,which is rotationally supported by knuckle pulley holder 840, which inturn is biased by a guide spring 845 against bracket 870 to maintaintension on cables 532, 534. FIGS. 83-85 further illustrate fittings 830,spring 835 and spring 845.

FIGS. 86(A)-86(B) illustrate the movement of shuttle 888 (FIGS.99(A)-99(B)), which moves proximally upon the release of trigger 700.Proximal movement of shuttle 888 prevents handle 892 r from beingarticulated, which, in turn, prevents guides 120, 130 from beingwithdrawn into suture head 100, 100′ while trigger 700 is actuated,advancing the needle (e.g., 300) about circular needle track 140, 140′.Components 830, 835 have been removed in FIG. 86 to better illustratelower brake pad 850. Brake pads 820, 850 are preferably made fromresilient and somewhat compressible material, such as silicone. FIG.87(A) further illustrates lower brake pad 850, while FIGS. 87(B)-87(D)illustrate brake bracket 860. Bracket 860 defines a circular boss 862thereon for receiving lower brake pad 850, as well as brake handlecomponents 882, 884, 884 a (FIG. 91(B)). FIGS. 88-89(A) illustrateremaining inner workings of handle with brake pad removed (FIG. 88) andfurther with pulley holder 840 and brake bracket 860 removed. FIGS.89(A)-89(B) further illustrates coupling knuckle 872, which includeslongitudinal openings 872 a having narrowed portions 872 c that are wideenough to permit passage of a cable 532, 534, but not wide enough topermit passage of cable terminations 874 (FIG. 91). Opening 872 b, incontrast, is large enough to permit terminations 874 to pass intoknuckle 872, thus joining cable 532 to cable 534, and providing a closedloop to facilitate articulation by way of articulation and brake control800. Brake trigger 884 can be pulled, causing a camming effect of bymoving an upper portion of handle component 882 (and its counterpart onthe left side of the device) into contact with lower brake pad 850,causing the brake pad 850 to compress components 830 between the upperand lower brake pads 820, 850.

FIGS. 92-102 illustrate aspects of the operation and control for theguides 120, 130 as well as the locking mechanism for trigger 700. Guides120, 130 are deployed or withdrawn by rotating handles 892. Cables172-178 are routed over guide 885, which is held in place by housingcomponents 612, 614 and are split up into two pairs of wires, whereinone set of wires is directed downwardly around spring loaded pulleys 894a, 896 a and routed up to handles 192 where all four cables, 172, 174,176, 178 are held in place in openings 892 b in handles 892 by taperedpins 893. The other pair of cables is routed about guide 887 directlyinto handles 892. Guide 885 (FIG. 93(B)) is a generally curved planarmember having a plurality of cable guides 885 a, wherein the cables172-178 bear over its upper surface on their route to handles 892. FIG.93(A) illustrates guides 887 and 885 in situ in relation to otherinternal components of handle 600. Guide 887 (FIGS. 93(C)-93(D)) includebosses 887 a to be received by housing portions 612, 614, and grooves887 b defined by fins 887 c for routing cables/wires. Handles 892include grips 892 a and grooves 892 c and channels 892 d for directingcables/wires into openings 892 b (FIGS. 94(A)-94E). Both handles 892 canbe essentially identical in form.

Guide handles 892 also play a role in releasing trigger lock 780,thereby permitting trigger 700 to actuate the movement of needle (e.g.,300). As illustrated in FIGS. 95(A)-95(B), trigger lock 780 is attachedto a cable at ferrule 781, which is disposed in opening 783 atbifurcation 782 of trigger lock (FIGS. 95(C)-95(D)). Trigger lock 780 isslidably disposed on a cylindrical rail 786, and is biased toward alocked position by spring 787. A bifurcation 784 at the opposite end oftrigger lock 780 is adapted and configured to interlock with trigger700. When the cable to which ferrule 781 is attached is advancedupwardly (FIG. 95(B)) by rotating handle 892L, bifurcation 784 oftrigger lock 780 disengages from trigger 700, permitting free movementof trigger. Handles 892L, 892R are pivotally disposed on axle 891 (FIGS.96, 122). FIGS. 97-101 further illustrate additional features of theactuation system for guides 120, 130 with progressively additionalcomponents removed to better illustrate other components, and theirrelative positions. FIG. 102 further illustrates additional aspects andviews of components 840, 894, 896.

FIGS. 103-113 illustrate aspects of the operation of reciprocatingtrigger mechanism 700. FIG. 103 illustrates the relative positions oftrigger 700, pull cable/ribbon 710, trigger spring capsule 720, triggerreturn spring 730, pull cable 727 and pulley 750. FIG. 103 removescomponents 786, 787 and handle 700 to reveal ferrule 752, which is fixedto a terminal end of pull cable 727 and resides within an opening 701within handle 700 (FIG. 105). Trigger 700 is further illustrated inFIGS. 106(A)-106(B) from two additional angles, showing bifurcated yoke702 proximate the top end of trigger 700. Yoke cap 704 is received intrigger handle 700 by securing studs 704 a into holes 700 a byinterference fit and/or ultrasonic welding, adhesive or the like. Yoke702 and yoke cap 704 define openings 702 a, 704 a therein for receivingbosses 888 a of shuttle link 888 (FIG. 99(B)). FIG. 107(A) illustratesthe interior of capsule 720, revealing clutch spring 724. FIGS.107(B)-107(C) illustrate housing portion 720 a, which mates with housingportion 720 b. Housing portion 720 b is an identical minor image ofportion 720 a, so only 720 a is illustrated. Clutch spring 724 isremoved in FIG. 108, clearly illustrating pull cable 727, clutch springferrule 723 and clutch washer 726. FIG. 109 illustrates the assemblywith spring 730 and housing portion 720 b removed. FIG. 110 illustratesa closeup of the connection of drive member 710 to assembly 720, showingthe manner in which tabs 711, 712 at proximal end of drive member 710are bent and inserted through the slot 721 a in washer plate 721.O-rings 720, which may be silicone or other suitable material, areillustrated in FIGS. 104 and 109. O-rings 729 provide a seal againsthousing segments 612, 614. Ferrule 723 is secured to cable 727. FIGS.111-113 provide closer views of ferrule 723, washer plate 721 andproximal end of member 710, respectively.

FIGS. 114-120 further illustrate the connections between drive member710 and drive members 150/551. As illustrated in FIG. 114, proximaldrive member, which can include ribbon-element 150 described aboveattached to intermediate cable section 551 in intermediate region 500,is received by a ferrule 910 which is affixed in place after termination930 is attached, and positioned into cavity 922 in coupling by passingcable/rod 551 through slot 924 in coupling 920. Rounded portion 932 oftermination faces distally, permitting movement between member 551 andcoupling 920. As illustrated in FIGS. 115-117, termination 930 defines apassage 936 therethrough for receiving cable 551, and defines agenerally cylindrical proximal section 934. Ferrule 910 defines apassage 912 therethrough for receiving cable 551, and a transverseopening 914 therethrough, such as for receiving brazing or solderingmaterial or other material for holding ferrule in place on cable 551.Coupling 920 includes a proximal face 922 a, a distal face 928 and abore 922 therethrough. As illustrated in FIG. 114 in cooperation withFIGS. 118-120, threaded male fitting 940 is received within threadedopening 922 of coupling, and receives a retaining hex nut 950 thereon.Proximal end 943 of fitting 940 faces proximally, and defines a cavity946 therein for receiving distal tip 717 of drive ribbon/cable 710. Tip717 is inserted into cavity 946 until stop 719 contacts proximal face943. Threads 942, 952 are defined on fitting 940 and nut 950. Components940, 710 may be coupled by any suitable means, including but not limitedto interference fit and/or welding, soldering, brazing, adhesive and thelike. FIGS. 121-122 illustrate torsion spring 960 and guide spring 970and their positioning with respect to the other components within handle600. Springs 960, 970 are a part of the control mechanism for deployingand retracting guides 120, 130. Return spring 895, 897 is illustrated inFIG. 121(C).

An exemplary method of operation of suture head 100 is set forth inFIGS. 123-131. FIG. 123 illustrates a cutaway view of suture head 100with needle 300 disposed therein in a delivery configuration with guides120, 130 retracted. Needle 300 is wholly contained within device 1000,and pawl spring 115 b prevents needle 300 from moving in acounterclockwise direction. Similarly, pawl spring 115 a is biasedagainst the inner circumferential surface 322 of needle, tending toprevent needle from moving in a clockwise direction. As set forth inFIGS. 123-131, it is apparent from the instant disclosure that the drivesystem of the device 1000 is adapted and configured to advance theneedle 300 in multiple 360° revolutions about the needle track when theneedle track is in a deployed condition. It is further evident that theneedle track is about 180° in extent prior to deployment, and greaterthan 180° in angular extent after deployment.

FIG. 124 illustrates the initial deployment of guides. Pawl 115 a isdragged along surface 322 of needle 300 until it engages with notch 308and pawl 115 b engages with notch 306. Guides are then fully retractedin FIG. 125, and pawl 115 a situated in guide 120 drags needle 300 in aclockwise direction to present it for suturing. Pawl 160 meanwhile isadvanced along its arcuate track along guides 120, 130 to its distalmostextent, causing notch 158 in the drive member 150 to align with boss 108a, and pawl 115 b bears against surface 122 of needle 300. When drivemember 150 is then pulled proximally, notched region 158 of member 150slips past bosses 106 a, 108 a and drive member 150 drops into lowerpassage defined in part by passage 108T. Further proximal movement ofdrive member 150 causes the distally located wider portion of ribbon 150to bear against the underside of bosses 106 a, 108 a, and pawl 160 makescontact with the trailing end of the needle 300, and needle is advancedabout 180°, as illustrated in FIG. 126. The distal movement of pawl 160is then repeated, such that pawl 160 engages with notch 310 in needle300. Region 158 slips past bosses 106 a, 108 a as before, and pawl 160and the leading tip 302 of needle are pulled along the arcuate needletrack 140, resulting in the needle being returned to its starting point,as illustrated in FIG. 128. FIG. 129 illustrates guides 120, 130 inpartial retraction such that needle is moved counterclockwise untilnotch 306 meets with pawl 115 b. FIG. 130 illustrates guides 120, 130retracted even further, illustrating how pawl 115 a is pulled out ofnotch 308 and is dragged along surface 322 of needle. furthercounterclockwise movement of needle 300 is prevented by pawl 115 b beinglocked into notch 306. FIG. 131 illustrates suture head 110 once againin delivery or removal configuration with guides 120, 130 fullywithdrawn. Thus, a device is provided herein that can rotate thedisclosed needle through 180°, 360°, or any further multiple of 180° asdesired. If desired, the angular increments of advancement could beincrements of more or less than 180° as desired.

The suturing devices of the presently disclosed embodiments can be usedfor laparoscopic procedures, including but not limited to laparoscopiccolostomy, colectomy, adrenalectomy, splenectomy, repair ofparaesophageal hernia, inguinal hernia repair, ventral hernia repair,Nissen fundoplication, liver lobectomy, gastrectomy, small bowelresection, treatment of small bowel obstruction, distal pancreatectomy,nephrectomy and gastric bypass. Those skilled in the art will recognizethat the presently disclosed embodiments can be used in otherlaparoscopic procedures.

In using the devices of the presently disclosed embodiments, the abdomenis insufflated with gas to create a working space for the user. Any gasknown to those skilled in the art including, but not limited to,nitrogen or carbon dioxide, can be used. Access portals are establishedusing trocars in locations to suit the particular surgical procedure. Avariety of surgical instruments may then be inserted into the bodythrough these access ports/cannulas. The user then introduces the distalend portion of the suturing device into a cannula, and then articulatesthe suture head assembly (e.g., 100, 100′). The suture head assembly isthen positioned relative to the tissue/vessel to be sutured together,and the user preferably locks the suture head assembly in place. Theuser then, through manipulation of the suturing device, positions aplurality of separated tissue segments into the opening defined at thedistal end portion of the suture head assembly. The user, using only onehand, may manipulate the device while actuating the handle to close anincision with a continuous suture whose stitches may be individuallytensioned precisely and uniformly along the length of the suture similarto suturing done by hand in the conventional way. The user may employ asingle suture which would extend the entire length of the incision ormultiple sutures. Thus, by placement of the device spanning the incisedtissue segments and actuating the handle, the suturing device enablesthe user to lay down a running stitch or interrupted stitch to close thetissue incision in a time efficient manner. Those skilled in the artwill recognize that any conventional procedure for conductinglaparoscopic surgery can be used with the device.

The minimalized structural design of the suture head assembly enablesthe user to have a clear, unobstructed view of the suturing needleduring advancement through the tissue segments during the course of asuturing operation, thereby enabling precise placement of the suturingdevice to provide uniform sutures and precluding the risk of tearingtissue by placement too close to the edge of the incision. The suturingdevice is then advanced a short distance along the incision and theaforementioned operation is repeated to produce another stitchcomprising the suturing material or thread.

The user may continue to manipulate the suturing device, alternatelyadvancing and actuating rotation of the needle about an axis that isgenerally parallel to the direction of advancement to create acontinuous suture which may extend through the entire length of theincision or a series of interrupted stitches. After each individualstitch is laid down, the stitch is tightened by exerting a pull on thesuturing material or thread so that the resultant suture is tensioneduniformly along the length of the incised tissue segments. Therefore, atight closure of the segments is accomplished and bleeding and tearingof tissue are minimized. Once the appropriate amount of suture materialor thread 246 has been placed, the user can use a needle grasper totighten and knot the formed stitches.

All patents, patent applications, and published references cited hereinare hereby incorporated by reference in their entirety. It will beappreciated that various of the above-disclosed and other features andfunctions, or alternatives thereof, may be desirably combined into manyother different systems or applications. Various presently unforeseen orunanticipated alternatives, modifications, variations, or improvementstherein may be subsequently made by those skilled in the art which arealso intended to be encompassed by the present disclosure.

1. A suturing needle having an arcuate body with a leading tip and atrailing end, wherein the arcuate body defines a first notch along aninner radial region needle and a second notch having a projection thatlies within a plane that is defined by a central curved axis of theneedle, and further wherein the first notch and second notch intersect.2. The suturing needle of claim 1, wherein the needle further includes agenerally square cross-section.
 3. The suturing needle of claim 2,wherein the needle body includes a portion with a round cross sectionthat separates a main portion of the needle with a generally squarecross section from a tail portion with a generally square cross section.4. The suturing needle of claim 1, wherein the needle further defines athird notch in the needle proximate its trailing end for receiving aportion of a drive pawl.
 5. The suturing needle of claim 1, furtherdefining an arcuate keel along its length.